NCT06637631

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	SAR441566	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	SAR441566 matching Placebo	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2024-12-10
• Primary completion: 2027-07-21
• Completion: 2029-05-23
• First posted: 2024-10-15
• Last updated: 2026-03-23

Locations

135 sites across 24 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, France, Georgia, Germany, Hungary, India, Italy, Japan, Mauritius, Netherlands, Poland, Romania, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study